Allogeneic Hematopoietic Stem Cell Transplantation RecipientEarly Phase 1NCT03665675
Donor Virus-Specific CMV or AdV CTL to Treat CMV or AdV Reactivation or Disease After Solid Organ or HCT
A Early Phase 1 study testing Allogeneic Cytomegalovirus-Specific Cytotoxic T lymphocytes and Allogeneic Adenovirus-specific Cytotoxic T Lymphocytes in people with Allogeneic Hematopoietic Stem Cell Transplantation Recipient and Cytomegalovirus, run by Sumithira Vasu at 2 sites in United States.
Trial summary
This trial studies the side effects and how well allogeneic cytomegalovirus-specific cytotoxic T lymphocytes (donor cytomegalovirus [CMV] specific cytotoxic T-lymphocytes [CTLs]) or allogeneic adenovirus-specific cytotoxic T lymphocytes (donor adenovirus-specific [AdV] specific CTLs) work in treating CMV or AdV… Read more about this study
- Who is it for?
- Ages 1 year to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Allogeneic Hematopoietic Stem Cell Transplantation Recipient, Cytomegalovirus, Donor
- What is being tested?
- Allogeneic Cytomegalovirus-Specific Cytotoxic T lymphocytes and Allogeneic Adenovirus-specific Cytotoxic T Lymphocytes
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Nov 2020to 20 Jun 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 85 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients must have solid organ transplant or have received allogeneic hematopoietic stem cell transplant.
- • Cohort A (CMV): Must have documented CMV disease or reactivation, as by:
- Viremia as detected by quantitative polymerase chain reaction (PCR) (> 500 IU/ml) in the peripheral blood requiring treatment OR
- High risk for antiviral failure due to history of recurrent CMV reactivations or evidence of antiviral drug resistance, OR
- Unable to tolerate antiviral drugs due to renal toxicity, bone marrow suppression, transfusion dependent anemia and thrombocytopenia or neutropenia requiring growth factor support or other related organ injury
- Cohort B (AdV): Must have documented AdV infection or reactivation, as by:
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- Symptomatic subject with any detectable viral load in blood, OR
- Symptomatic subject with qualitative AdV detection in compartment of current symptomatology, including stool, urine, and/or other specimens (bronchoalveolar lavage (BAL), nasal swab, CSF, etc.), irrespective of blood viral load, OR
- New, persistent, and/or worsening AdV-related symptoms, signs, and/or markers of end organ compromise while receiving antiviral therapy (ie cidofovir), OR
- Asymptomatic with a viral load > 1000 copies/ml in peripheral blood, OR
- Unable to tolerate antiviral treatment due to renal toxicity, bone marrow suppression, transfusion dependent anemia and thrombocytopenia or neutropenia requiring growth factor support or other related organ injury
- Karnofsky (age > 16 years) or Lansky performance score > 70 (age < 16)
- Available seropositive haploidentical or matched donor who is without evidence of infection that would otherwise preclude donation
- Negative pregnancy test in female patients if applicable (childbearing potential, has not received a full-intensity conditioning regimen
- Written informed consent and/or signed assent line from patient, parent or guardian
- DONOR
- Human leukocyte antigen (HLA)-haploidentical or full-match to the patient as determined by institutional standards
- Cohort A: CMV seropositive, defined as detection of serum CMV immunoglobulin G (IgG)
- Cohort B: AdV seropositive, defined as detection of serum AdV IgG
- Age 18 or over
- Meet donor eligibility or suitability according to institutional standards. If the donor is deemed ineligible according to Foundation for the Accreditation of Cellular Therapy (FACT) standards, but is suitable for donation per institutional standards, the donor will be eligible for the protocol
Who cannot join
- Receipt of anti-thymocyte globulin (ATG), alemtuzumab, or other T-cell depleting agents within 21 days of screening for enrollment.
- Receipt of > 0.5mg/kg/day of prednisone or steroid equivalent at the time of enrollment. Stable GVHD is permitted as long as patients are on stable dose steroids of less than or equal to 0.5 mg/kg/day of prednisone or steroid equivalent.
- Evidence of uncontrolled infection as follows:
- Bacterial infections - patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment.
- Fungal infections - patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment.
- Patients with hemodynamic instability attributable to bacterial sepsis or new symptoms, worsening physical signs or radiographic findings attributable to concomitant bacterial or fungal infection are excluded. Patients who require ventilator support for CMV pneumonitis are not excluded. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
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- Receipt of donor lymphocyte infusion (DLI) within 28 days.
- Patients with active acute graft versus host disease (GvHD) grades II-IV requiring > 0.5 mg/kg/day of prednisone or steroid equivalent or T-cell depleting immunosuppression.
- Acute graft rejection in solid organ transplantation requiring augmented immunosuppression with T-cell depleting agents or steroids as mentioned above.
- Active and uncontrolled relapse of malignancy.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
The Ohio State University Comprehensive Cancer Center contact
United States2 sites, 1 recruiting
- Recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
Chris Ouellette, MD
Melinda Triplet, RN, BSN, 614-722-6039, Melinda.Triplet@nationwidechildrens.org
- Suspended
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: Pilot Study of Haploidentical or Matched Donor Virus-Specific T-cells (Cytomegalovirus (CMV) or Adenovirus (AdV)) to Treat CMV or AdV Reactivation or Disease in Patients After Solid Organ or Hematopoietic Stem Cell Transplantation (HCT)
This trial studies the side effects and how well allogeneic cytomegalovirus-specific cytotoxic T lymphocytes (donor cytomegalovirus [CMV] specific cytotoxic T-lymphocytes [CTLs]) or allogeneic adenovirus-specific cytotoxic T lymphocytes (donor adenovirus-specific [AdV] specific CTLs) work in treating CMV or AdV reactivation or infection in participants who have undergone stem cell transplant or solid organ transplant. White blood cells from donors may be able to kill cancer cells in patients with cytomegalovirus or adenovirus that has come back after a stem cell or solid organ transplant.
Read the detailed description
PRIMARY OBJECTIVE I. Assess the safety and feasibility of administering virus specific-CTLs from haploidentical donors in transplant patients both solid organ transplantation (SOT) and hematopoietic cell transplantation (HCT) with CMV/AdV infection despite standard therapy.
OUTLINE:Patients are assigned to 1 of 2 Cohorts.
COHORT A: Patients receive allogeneic cytomegalovirus-specific cytotoxic T lymphocytes intravenously (IV). Patients undergo blood, urine, saliva, cerebrospinal fluid (CSF), and bronchoalveolar fluid sample collection on the trial.
COHORT B: Patients receive allogeneic adenovirus-specific cytotoxic T Lymphocytes IV. Patients undergo blood, urine, saliva, CSF, and bronchoalveolar fluid sample collection on the trial.
After completion of study treatment, participants are followed up at 1 year.
- Conditions
- Allogeneic Hematopoietic Stem Cell Transplantation Recipient, Cytomegalovirus, Donor, Solid Organ Transplantation Recipient, Adenovirus
- Being tested
- Allogeneic Cytomegalovirus-Specific Cytotoxic T lymphocytes, Allogeneic Adenovirus-specific Cytotoxic T Lymphocytes
- Medical subject headings
- Adenoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic Cytomegalovirus-Specific Cytotoxic T lymphocytesBiological
Given intravenously
Allogeneic Adenovirus-specific Cytotoxic T LymphocytesBiological
Given intravenously
| Study group | Role | What they receive |
|---|---|---|
| Treatment (CMV-specific CTLs) | Experimental | Participants receive allogeneic cytomegalovirus-specific cytotoxic T lymphocytes IV. Participants with persistent infection are eligible for second infusion after 28 days. Receives: Biological: Allogeneic Cytomegalovirus-Specific Cytotoxic T lymphocytes |
| Treatment (AdV-specific CTLs) | Experimental | Patients receive allogeneic adenovirus-specific cytotoxic T Lymphocytes IV. Participants with persistent infection are eligible for second infusion after 28 days. Receives: Biological: Allogeneic Adenovirus-specific Cytotoxic T Lymphocytes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events defined by the National Cancer Institute Common Terminology Criteria for Adverse Events 4.0
Measured as the proportion of patients with acute (a) graft versus host disease (GvHD) grades III-IV or graft rejection/failure within 30 days of the last dose of cytotoxic T-lymphocytes (CTLs) or grades 3-5 infusion-related adverse events within 7 days of the last does of CTLs or grades 4-5 non-hematological adverse events within 30 days of the last dose of CTLs and that are not due to the pre-existing infection or the original malignancy or pre-existing co-morbidities. Will be calculated by dividing by all evaluable patients and the corresponding 95% confidence intervals will be calculated.
Measured: Up to 30 days post infusion
Feasibility defined as identifying a suitable donor within 4 weeks and meeting minimum T cell doses in the final product
Measured: Up to 1 year
Secondary outcomes (10)
Antiviral activity defined as response to viral load
Complete response, partial response, stable disease or progression will be defined and proportion of each outcome will be calculated.
Measured: At day 28
Persistence of infused CTLs as measured by T cell gene rearrangement and effects on clinical signs of viral infection
Measured: Up to 1 year
Overall survival
Kaplan-Meier survival function will be used to estimate the survival probability.
Measured: From last CTL infusion till death, assessed at 6 and 12 months
Risk for chronic GVHD
Survival analysis method will be applied. Time to chronic GVHD will be defined from time of the last CTL infusion to the onset of chronic GVHD, or the last clinical assessment date if no chronic GVHD. Cumulative incidence of chronic GVHD at 6 and 12 months will be estimated.
Measured: At 6 and 12 months post CTL infusion
Systemic infections
Will be reported by etiologic agent, site of disease, date of onset, and severity.
Measured: Within 6 months of CTL infusion
Secondary graft failure
Proportion of secondary graft failure for both populations will be assessed at 30 days post CTL infusion will be calculated and 95% confidence intervals will be estimated accordingly.
Measured: 30 days post-CTL infusion
Effects of cytomegalovirus (CMV) specific-CTL on viral loads assessed by weekly reverse transcriptase-polymerase chain reaction
Measured: Up to 1 year
Viral reactivations
Proportion of viral reactivations within 6 months will be calculated and 95% confidence intervals will be estimated accordingly.
Measured: Up to 6 months
Clinical response to CTL infusions
Measured: At 6 weeks and 3 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0".
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start7 Nov 2020
- Primary completion20 Mar 2027 (estimated)
- Study completion20 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allogeneic Hematopoietic Stem Cell Transplantation RecipientStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sumithira Vasu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sumithira Vasu, Ohio State University Comprehensive Cancer Center
- Investigators
- Sumithira Vasu, MBBS, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03665675
- Sponsor's protocol ID
- OSU-17199
- Other IDs
- NCI-2018-01412
- Status last verified
- Mar 2026
- First submitted
- 13 Aug 2018
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Haploidentical or Matched Donor Virus-Specific T-cells (Cytomegalovirus (CMV) or Adenovirus (AdV)) to Treat CMV or AdV Reactivation or Disease in Patients After Solid Organ or Hematopoietic Stem Cell Transplantation (HCT)
- ClinicalTrials.gov ID
- NCT03665675
- Acronym / sponsor ID
- OSU-17199
- Conditions
- Allogeneic Hematopoietic Stem Cell Transplantation Recipient, Cytomegalovirus, Donor, Solid Organ Transplantation Recipient, Adenovirus
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sumithira VasuUniversity, hospital or other
- Study start
- 7 Nov 2020 (actual)
- Primary completion
- 20 Mar 2027 (estimated)
- Study completion
- 20 Jun 2027 (estimated)
- First posted
- 11 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial studies the side effects and how well allogeneic cytomegalovirus-specific cytotoxic T lymphocytes (donor cytomegalovirus [CMV] specific cytotoxic T-lymphocytes [CTLs]) or allogeneic adenovirus-specific cytotoxic T lymphocytes (donor adenovirus-specific [AdV] specific CTLs) work in treating CMV or AdV reactivation or infection in participants who have undergone stem cell transplant or solid organ transplant. White blood cells from donors may be able to kill cancer cells in patients with cytomegalovirus or adenovirus that has come back after a stem cell or solid organ transplant.
Detailed description
PRIMARY OBJECTIVE I. Assess the safety and feasibility of administering virus specific-CTLs from haploidentical donors in transplant patients both solid organ transplantation (SOT) and hematopoietic cell transplantation (HCT) with CMV/AdV infection despite standard therapy.
OUTLINE:Patients are assigned to 1 of 2 Cohorts.
COHORT A: Patients receive allogeneic cytomegalovirus-specific cytotoxic T lymphocytes intravenously (IV). Patients undergo blood, urine, saliva, cerebrospinal fluid (CSF), and bronchoalveolar fluid sample collection on the trial.
COHORT B: Patients receive allogeneic adenovirus-specific cytotoxic T Lymphocytes IV. Patients undergo blood, urine, saliva, CSF, and bronchoalveolar fluid sample collection on the trial.
After completion of study treatment, participants are followed up at 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment (CMV-specific CTLs) | Experimental | Biological: Allogeneic Cytomegalovirus-Specific Cytotoxic T lymphocytesParticipants receive allogeneic cytomegalovirus-specific cytotoxic T lymphocytes IV. Participants with persistent infection are eligible for second infusion after 28 days. |
| Treatment (AdV-specific CTLs) | Experimental | Biological: Allogeneic Adenovirus-specific Cytotoxic T LymphocytesPatients receive allogeneic adenovirus-specific cytotoxic T Lymphocytes IV. Participants with persistent infection are eligible for second infusion after 28 days. |
Who may qualify
- Ages
- 1 year to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (21 listed)
- Patients must have solid organ transplant or have received allogeneic hematopoietic stem cell transplant.
- • Cohort A (CMV): Must have documented CMV disease or reactivation, as by:
Key exclusion criteria (10 listed)
- Receipt of anti-thymocyte globulin (ATG), alemtuzumab, or other T-cell depleting agents within 21 days of screening for enrollment.
- Receipt of > 0.5mg/kg/day of prednisone or steroid equivalent at the time of enrollment. Stable GVHD is permitted as long as patients are on stable dose steroids of less than or equal to 0.5 mg/kg/day of prednisone or steroid equivalent.
- Evidence of uncontrolled infection as follows:
- Receipt of donor lymphocyte infusion (DLI) within 28 days.
- Patients with active acute graft versus host disease (GvHD) grades II-IV requiring > 0.5 mg/kg/day of prednisone or steroid equivalent or T-cell depleting immunosuppression.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allogeneic Cytomegalovirus-Specific Cytotoxic T lymphocytesGiven intravenously | Biological | Treatment (CMV-specific CTLs) |
| Allogeneic Adenovirus-specific Cytotoxic T LymphocytesGiven intravenously | Biological | Treatment (AdV-specific CTLs) |
Primary outcome
Incidence of adverse events defined by the National Cancer Institute Common Terminology Criteria for Adverse Events 4.0
Time frame: Up to 30 days post infusion
Measured as the proportion of patients with acute (a) graft versus host disease (GvHD) grades III-IV or graft rejection/failure within 30 days of the last dose of cytotoxic T-lymphocytes (CTLs) or grades 3-5 infusion-related adverse events within 7 days of the last does of CTLs or grades 4-5 non-hematological adverse events within 30 days of the last dose of CTLs and that are not due to the pre-existing infection or the original malignancy or pre-existing co-morbidities. Will be calculated by dividing by all evaluable patients and the corresponding 95% confidence intervals will be calculated.
Feasibility defined as identifying a suitable donor within 4 weeks and meeting minimum T cell doses in the final product
Time frame: Up to 1 year
10 secondary outcomes
Antiviral activity defined as response to viral load
Time frame: At day 28
Persistence of infused CTLs as measured by T cell gene rearrangement and effects on clinical signs of viral infection
Time frame: Up to 1 year
Overall survival
Time frame: From last CTL infusion till death, assessed at 6 and 12 months
Risk for chronic GVHD
Time frame: At 6 and 12 months post CTL infusion
Systemic infections
Time frame: Within 6 months of CTL infusion
Secondary graft failure
Time frame: 30 days post-CTL infusion
Effects of cytomegalovirus (CMV) specific-CTL on viral loads assessed by weekly reverse transcriptase-polymerase chain reaction
Time frame: Up to 1 year
Viral reactivations
Time frame: Up to 6 months
Clinical response to CTL infusions
Time frame: At 6 weeks and 3 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0".
Time frame: Up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The Ohio State University Comprehensive Cancer Center contact
Sumithira Vasu, MBBS principal investigator
Ohio State University Comprehensive Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Allogeneic Cytomegalovirus-Specific Cytotoxic T lymphocytes and Allogeneic Adenovirus-specific Cytotoxic T Lymphocytes in people with Allogeneic Hematopoietic Stem Cell Transplantation Recipient and Cytomegalovirus, run by Sumithira Vasu at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact The Ohio State University Comprehensive Cancer Center (800-293-5066, OSUCCCClinicaltrials@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events defined by the National Cancer Institute Common Terminology Criteria for Adverse Events 4.0 (time frame: Up to 30 days post infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.